ARCALYST Drug Profile

Summary for Tradename: ARCALYST

High Confidence Patents:	3
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for ARCALYST
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARCALYST

Recent Clinical Trials for ARCALYST

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Stanley Cohen	Early Phase 1
Regeneron Pharmaceuticals	Early Phase 1
Regeneron Pharmaceuticals	Phase 2

See all ARCALYST clinical trials

Recent Litigation for ARCALYST

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29

See all ARCALYST litigation

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for ARCALYST Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ARCALYST Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249		2013-10-20	Company disclosures
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249		2018-09-25	Company disclosures
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249		2018-09-25	Company disclosures

3) Low Certainty: US Patents for ARCALYST Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249		2034-04-21	Patent claims search
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249		2031-03-09	Patent claims search
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249		2034-12-04	Patent claims search
Kiniksa Pharmaceuticals (uk), Ltd.	ARCALYST	rilonacept	For Injection	125249		2037-01-12	Patent claims search

International Patents for ARCALYST

Country	Patent Number	Estimated Expiration
New Zealand	510720
Brazil	0315652
Hong Kong	1045847
Japan	4387309

Supplementary Protection Certificates for ARCALYST

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122010000023	Germany		PRODUCT NAME: RILONACEPT; REGISTRATION NO/DATE: EU/1/09/582/001 20091023
SZ 15/2010	Austria		PRODUCT NAME: RILONACEPT
CA 2010 00016	Denmark		PRODUCT NAME: RILONACEPT
15/2010	Austria		PRODUCT NAME: RILONACEPT; REGISTRATION NO/DATE: EU/1/09/582/001 20091023

ARCALYST Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for ARCALYST

Introduction to ARCALYST

ARCALYST, also known as rilonacept, is a groundbreaking drug approved by the FDA for the treatment of recurrent pericarditis and other autoinflammatory diseases. It functions as an interleukin-1 alpha (IL-1α) and interleukin-1 beta (IL-1β) cytokine trap, making it a unique and effective therapy in its class[4][5].

Market Approval and Indications

ARCALYST was first approved in 2008 for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) and later received approval in 2021 for the treatment of recurrent pericarditis in adults and children 12 years and older. This expansion in indications has significantly broadened its market potential[4].

Market Size and Growth Projections

The global market for rilonacept drugs, primarily driven by ARCALYST, is forecasted to grow from $13 million in 2023 to $17 million by 2030, with a Compound Annual Growth Rate (CAGR) of 4.1% during the period 2024-2030. This growth is driven by the increasing demand for effective treatments for rare autoinflammatory diseases[1].

Revenue Performance

ARCALYST has demonstrated robust revenue growth since its launch. In the third quarter of 2024, ARCALYST net product revenue reached $112.2 million, representing a 73% year-over-year growth. For the full year 2024, Kiniksa Pharmaceuticals has raised its net sales guidance for ARCALYST to between $410 million and $420 million, up from the previous range of $405 million to $415 million[2][3].

Prescriber Adoption and Disease Awareness

The success of ARCALYST is also attributed to the increasing number of prescribers. As of the third quarter of 2024, more than 2,550 prescribers have written ARCALYST prescriptions for recurrent pericarditis. Kiniksa's disease awareness campaigns, such as the "Life DisRPted" campaign, have played a crucial role in promoting early diagnosis and treatment, thereby driving prescriber adoption[2][3].

Clinical Pipeline and Future Prospects

Kiniksa Pharmaceuticals is actively advancing its clinical pipeline, including ongoing trials for abiprubart in Sjögren's disease. This focus on expanding the therapeutic portfolio is expected to contribute to the company's long-term growth and market dominance[2][3].

Financial Health and Cash Reserves

Despite reporting a net loss of $12.7 million in the third quarter of 2024, Kiniksa's financial health remains robust. The company has $223.8 million in cash reserves and no debt, providing the necessary financial flexibility to continue investing in its commercial strategies and clinical pipeline[2][3].

Operational Expenses and Profitability

The operating expenses for the third quarter of 2024 included significant costs related to the commercialization of ARCALYST, collaboration expenses, and research and development. However, ARCALYST has been profitable since the fourth quarter of 2021, and the company expects to remain cash flow positive on an annual basis[2][3].

Market Penetration and Treatment Duration

ARCALYST has achieved notable market penetration, with about 11% of the targeted patient population reached. The median treatment duration for patients on ARCALYST is approximately 27 months, indicating strong ongoing demand and patient adherence to the therapy[3].

Regulatory and Safety Considerations

ARCALYST received orphan drug designation for the treatment of recurrent pericarditis, highlighting its importance in addressing a significant unmet medical need. However, it is associated with serious side effects, including life-threatening infections, and patients with active or chronic infections should avoid the drug. Additionally, patients should not receive live vaccines while taking ARCALYST[4].

Competitive Landscape

The market for rilonacept drugs is currently dominated by Kiniksa Pharmaceuticals, with ARCALYST being the primary product. The company's strategic investments in brand and disease awareness, along with its expanding salesforce, have helped maintain its competitive edge[2][3].

Key Takeaways

• Revenue Growth: ARCALYST net product revenue has shown significant year-over-year growth, with a projected full-year revenue of $410-420 million for 2024.
• Prescriber Adoption: Over 2,550 prescribers have written ARCALYST prescriptions, driven by effective disease awareness campaigns.
• Financial Health: Kiniksa has substantial cash reserves and expects to remain cash flow positive.
• Clinical Pipeline: Ongoing trials for abiprubart in Sjögren's disease are a key focus for future growth.
• Market Penetration: About 11% of the targeted patient population has been reached, with a median treatment duration of 27 months.

FAQs

What is ARCALYST used for?

ARCALYST (rilonacept) is used for the treatment of recurrent pericarditis and other autoinflammatory diseases such as Cryopyrin-Associated Periodic Syndromes (CAPS)[4].

How has ARCALYST performed financially in 2024?

In the third quarter of 2024, ARCALYST net product revenue reached $112.2 million, a 73% year-over-year growth. Full-year 2024 net sales guidance has been raised to between $410 million and $420 million[2][3].

What are the key drivers of ARCALYST's market growth?

The growth is driven by increasing demand for effective treatments for rare autoinflammatory diseases, successful disease awareness campaigns, and expanding prescriber adoption[1][2].

What are the potential risks associated with ARCALYST?

ARCALYST is associated with serious side effects, including life-threatening infections. Patients with active or chronic infections should avoid the drug, and live vaccines should not be administered while taking ARCALYST[4].

How is Kiniksa Pharmaceuticals positioned financially?

Kiniksa has $223.8 million in cash reserves and no debt, allowing the company to remain cash flow positive and invest in its commercial strategies and clinical pipeline[2][3].

Cited Sources

1. Rilonacept Drugs - Market Size - Valuates Reports
2. Kiniksa Pharmaceuticals Reports Third Quarter 2024 - GlobeNewswire
3. Earnings call: Kiniksa Pharma's Q3 2024 shows strong ARCALYST sales growth - Investing.com
4. FDA approves first treatment for disease that causes recurrent inflammation of the sac surrounding the heart - FDA
5. 2023 Annual Report - Kiniksa Pharmaceuticals